510k
Database
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Anesthesiology
759
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2318
Chemistry
506
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1854
Ear, Nose, Throat
329
Gastroenterology & Urology
1347
General & Plastic Surgery
2884
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2558
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160
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145
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13
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625
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1285
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608
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393
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4050
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63
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614
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3254
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178
Categories
LLZ
System, Image Processing,...
551
LZA
Polymer Patient Examination Glove
464
GEX
Powered Laser Surgical Instrument
456
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Electrosurgical, Cutting &...
421
IYN
System, Imaging, Pulsed Doppler,...
412
FXX
Mask, Surgical
388
HRS
Plate, Fixation, Bone
364
MAX
Intervertebral Fusion Device...
333
OLO
Orthopedic Stereotaxic Instrument
300
QIH
Automated Radiological Image...
296
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Manufacturers
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Manufacturers
US
New Star Lasers, Inc.
Medical Device Manufacturer
·
US , Auburn , CA
New Star Lasers, Inc. - FDA 510(k) Cleared Devices
29 submissions
·
29 cleared
·
Since 1995
29
Total
29
Cleared
0
Denied
28
devices
26-28 of 28
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1
2
Cleared
Mar 13, 1997
NEW STAR MODEL 130 6-WATT ND: YAG LASER SYSTEM
K962791
·
GEX
General & Plastic Surgery
·
239d
Cleared
Jan 22, 1996
6 WATT HOLMIUM LASER SYSTEM
K952489
·
GEX
General & Plastic Surgery
·
237d
Cleared
Mar 09, 1995
SLASE 210 PLUS HOLMIUM LASER SYSTEM
K945156
·
GEX
General & Plastic Surgery
·
139d
1
2
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29
General & Plastic Surgery
28
Physical Medicine
1